Z-2674-2016 Class II Terminated
FDA device recall Z-2674-2016 was initiated by Nakanishi Inc. on July 8, 2016 and is designated Class II. Reason for recall: Through an error, the labeling failed to include the symbol or other text indicating that the diamond coated tips were single use only. A contributing factor to this error is that in other markets su… The recall status is terminated (terminated June 25, 2018). Affected quantity: 4284 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 7, 2016
- Initiation Date
- July 8, 2016
- Termination Date
- June 25, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4284 units
Product Description
Diamond Coated Tips and Burs are accessories to the air powered dental handpiece (S-MAX pico) The intended use of the tips is based on the parent device. For burs used with the dental handpieces, the intended use is general dental actions such as removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations and polishing teeth.
Reason for Recall
Through an error, the labeling failed to include the symbol or other text indicating that the diamond coated tips were single use only. A contributing factor to this error is that in other markets such as Japan, the diamond coated tips are multiple use and are not limited to single use only. The tips are stainless steel with a coating of fine diamond powder. The tips are sold non-sterile and are to be sterilized prior to first use. The tips were cleared as single use only. This problem was discovered during an ongoing, proactive, quality system improvement plan that was initiated by Nakanishi in October 2014. Because the correct instructions for sterilization are not available, it is possible that the devices might not be sterile prior to use. The absence of the single use statement introduces a risk of cross-contamination if the tips are reprocessed and reused.
Distribution Pattern
Nationwide Distribution to Illinois, Florida and Georgia.
Code Information
Waiting for clarification from the firm.